Correlation Between the Volume Flow of the CFA After Angioplasty of Critical Ischemic Limb and Wound Healing

Wound Heal, Duplex Volume Flow Clinical Trial

Official title:

Correlation Between the Volume Flow of the CFA After Angioplasty of Critical Ischemic Limb and Wound Healing

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04672668
• Other study ID #: SHEBA-20-7318-CP-CTIL
• Status: Active, not recruiting
• Start date: December 13, 2020
• Est. completion date: February 20, 2024

Study information

• Verified date: December 2020
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

in our study we are examining the volume flow of the common femoral artery before and after angigraphy of a critical ischemic limb, as a predictor for wound healing after the treatment

Description:

All patients with threatened limbs, that was decided upon to have angioplasty will be asked to sign consent form to participate in this study.

Before having the angioplasty, all participants will be examined with ultrasound duplex to determent their common femoral artery volume flow. Day after the angioplasty, they will be reexamined (this is the usual practice) to detriment the new volume flow in the CFA.

The participents examinations in the outpatient clinics will be documented and time for healing will be recorded.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: February 20, 2024
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 120 Years

Eligibility

Inclusion Criteria:

• All patients with threatened limbs, that was decided upon to have angioplasty .

Exclusion Criteria:

• those who are not willing to sign a consent form to participate in this study

Related Conditions & MeSH terms

• Wound Heal, Duplex Volume Flow
• Wounds and Injuries

Intervention

Diagnostic Test:
• duplex ultrasound for the common femoral artery
duplex ultrasound for the common femoral artery before and after the angiography

Locations

Country	Name	City	State
Israel	Sheba Health Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	wound healing	physical examination	12 months